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    DRUG:

    HLX22

    i
    Other names: HLX22, AC-101, AC101, HLX-22, HLX 22
    Company:
    AbClon, Alligator Biosci, Fosun Pharma
    Drug class:
    HER2 antagonist
    Related drugs:
    1m
    A Hase II/III Clinical Study to Evaluate HLX22 in Combination With HLX87 as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P2/3, N=706, Not yet recruiting, Shanghai Henlius Biotech
    New P2/3 trial
    |
    docetaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • HLX22
    1m
    A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer (clinicaltrials.gov)
    P2/3, N=817, Not yet recruiting, Shanghai Henlius Biotech
    New P2/3 trial
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • HLX22
    2ms
    A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Shanghai Zhongshan Hospital | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    Herceptin (trastuzumab) • albumin-bound paclitaxel • HLX22
    3ms
    A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy for the First-Line Treatment of HER2-Positive Pancreatic Ductal Adenocarcinoma (ChiCTR2500109825)
    P2, N=45, Not yet recruiting, ZHONGSHAN HOSPITAL; ZHONGSHAN HOSPITAL
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • gemcitabine • albumin-bound paclitaxel • HLX22
    8ms
    A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients (clinicaltrials.gov)
    P2, N=50, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • HLX22
    12ms
    A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • HLX22
    1year
    HLX22-GC-301: A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer (clinicaltrials.gov)
    P3, N=550, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • capecitabine • oxaliplatin • HLX22
    over1year
    A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer (clinicaltrials.gov)
    P3, N=550, Not yet recruiting, Shanghai Henlius Biotech
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • capecitabine • oxaliplatin • HLX22
    over1year
    A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. (PubMed, Med)
    Adding HLX22 to HLX02 and XELOX prolonged PFS and enhanced antitumor response in the first-line treatment of HER2-positive gastric cancer, with manageable safety.
    Clinical • P2 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    capecitabine • oxaliplatin • Hercessi (trastuzumab-strf) • HLX22
    over1year
    Dual targeting non-overlapping epitopes in HER2 domain IV substantially enhanced HER2/HER2 homodimers and HER2/EGFR heterodimers internalization leading to potent antitumor activity in HER2-positive human gastric cancer. (PubMed, J Transl Med)
    These results suggested that the application of non-competing antibodies HLX22 and HLX02 targeting HER2 subdomain IV together may be of substantial benefit to gastric cancer patients who currently respond suboptimal to trastuzumab therapy.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • FGFR (Fibroblast Growth Factor Receptor) • mTOR (Mechanistic target of rapamycin kinase) • STAT3 (Signal Transducer And Activator Of Transcription 3) • TGFB1 (Transforming Growth Factor Beta 1) • PI3K (Phosphoinositide 3-kinases)
    |
    Hercessi (trastuzumab-strf) • HLX22 • Poherdy (pertuzumab-dpzb)
    almost2years
    Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer (clinicaltrials.gov)
    P2, N=150, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Apr 2023 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • capecitabine • oxaliplatin • HLX22
    2years
    HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study. (ASCO-GI 2024)
    Adding HLX22 to HLX02 + XELOX improved survival and antitumor response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile. Clinical trial information: NCT04908813. >*Hazard ratio (HR) was estimated between group A and C, as well as between group B and C. NE, not evaluable; NR, not reached.
    Clinical • P2 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    capecitabine • oxaliplatin • Hercessi (trastuzumab-strf) • HLX22